A Study to Investigate the Effect of AZD6234 and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-04

Study Completion Date

2026-12-25

Brief Summary

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This study will measure the effects of multiple doses of AZD6234 and a combination of AZD6234 and AZD9550 given as injection(s) on pharmacokinetics (PK) of combined oral contraceptive ethinyl estradiol (EE)/levonorgestrel (LEVO) in healthy female participants with obesity.

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Detailed Description

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This is a Phase I, open-label, single-sequence, multiple-cohort study which will be performed at multiple study sites in healthy females of childbearing and non-childbearing potential.

The purpose of this study is to investigate the effect of AZD6234 and a combination of AZD6234 and AZD9550 on the PK, safety and tolerability of a combined oral contraceptive, ethinyl estradiol/levonorgestrel (EE/LEVO).

The study will have 2 cohorts, and each cohort will consist of 5 periods which include, Screening, Start, Up-titration, Maintenance, and Follow-up periods.

Conditions

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Healthy Participants

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort-1 AZD6234 + EE/LEVO + Acetaminophen (APAP)

Participants will receive combined oral contraceptive (EE/LEVO) and, separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 administration.

Group Type EXPERIMENTAL

AZD6234

Intervention Type DRUG

AZD6234 will be administered as a subcutaneous injection in the abdomen.

Ethinyl estradiol/Levonorgestrel (EE/LEVO)

Intervention Type DRUG

EE/LEVO will be administered as combined oral tablets.

Acetaminophen (APAP)

Intervention Type DRUG

APAP will be administered orally as a solution.

Cohort-2: AZD6234+AZD9550+EE/LEVO+APAP

All participants will receive combined oral contraceptive EE/LEVO and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous administered AZD6234 and AZD9550.

Group Type EXPERIMENTAL

AZD6234

Intervention Type DRUG

AZD6234 will be administered as a subcutaneous injection in the abdomen.

Ethinyl estradiol/Levonorgestrel (EE/LEVO)

Intervention Type DRUG

EE/LEVO will be administered as combined oral tablets.

Acetaminophen (APAP)

Intervention Type DRUG

APAP will be administered orally as a solution.

AZD9550

Intervention Type DRUG

AZD9550 will be administered as a subcutaneous injection in the abdomen.

Interventions

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AZD6234

AZD6234 will be administered as a subcutaneous injection in the abdomen.

Intervention Type DRUG

Ethinyl estradiol/Levonorgestrel (EE/LEVO)

EE/LEVO will be administered as combined oral tablets.

Intervention Type DRUG

Acetaminophen (APAP)

APAP will be administered orally as a solution.

Intervention Type DRUG

AZD9550

AZD9550 will be administered as a subcutaneous injection in the abdomen.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All participants must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
* Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.

o Hormonal contraceptives and estrogen-containing hormonal methods of birth control are not permitted due to potential effect and influence on the results using a combined oral contraceptive assessment.
* Females of non-childbearing potential must be confirmed at the Screening Visit.
* Have a Body Mass Index (BMI) ≥ 25 kg/m2 inclusive and weigh at least 60 kg.

Exclusion Criteria

* History of any clinically important disease or disorder (gastroparesis, deep vein thrombosis, venous thromboembolism, previous surgery of the upper gastrointestinal tract, cardiovascular disease, neuromuscular or neurogenic disease, severe vitamin D deficiency, type I or type II diabetes mellitus, glycated hemoglobin (HbA1c) ≥ 6.5% at screening, history of neoplastic disease, basal calcitonin level \>50 ng/L (50 pg/L) at screening (Cohort 2), history of acute or chronic pancreatitis or pancreatic amylase or lipase \>2×ULN at screening (cohort 2), prior history of cholecystectomy or untreated cholelithiasis and personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type 2 (MEN2) (cohort 2)).
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important illness, medical/surgical procedure, or trauma.
* Any laboratory values with deviations or clinically important abnormalities in clinical chemistry, hematology, or urinalysis.
* Any positive result on screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) or Human immunodeficiency virus (HIV).
* Abnormal vital signs.
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead electrocardiogram (ECG), at screening.
* Current smokers or those who have smoked or used nicotine products.
* Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
* Statin treatment within 4 weeks prior to the start of study treatment.
* Current use of estrogen-containing products.

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes